THE ASSESSMENT OF VERTEBRAL DEFORMITY - A METHOD FOR USE IN POPULATION STUDIES AND CLINICAL-TRIALS
THE ASSESSMENT OF VERTEBRAL DEFORMITY - A METHOD FOR USE IN POPULATION STUDIES AND CLINICAL-TRIALS
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DOI：
10.1007/bf01623275
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发表时间：
1993-05-01
影响因子：
4
通讯作者：
KANIS, JA
中科院分区：
文献类型：
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作者：
MCCLOSKEY, EV;SPECTOR, TD;KANIS, JA
脊椎骨折定义的具体标准的缺乏对评估脊椎畸形的明显患病率和发生率具有重要意义。此外，在临床研究中，对新发椎体骨折使用不同标准的影响知之甚少。因此，我们制定了女性椎体骨折的放射学标准，以评估人群和前瞻性研究中椎体骨质疏松症的患病率和发病率，并将其与其他几种已发表的方法进行比较。对100例45-50岁妇女的X线片进行了椎体形态的正常范围测定。这些包括T4至L5椎体前/后、中/后和后/预测后椎体高度的比值范围。根据相邻椎骨计算预测的后部高度。与其他方法相比。我们对骨折的定义要求在每个椎骨部位满足两个标准，并且由于假阳性率较低，与对照组妇女骨折的明显患病率较低相关。然后，在一系列患有乳腺癌骨转移的女性中，使用不同标准比较了椎骨畸形的患病率和发生率，这些女性的X光片拍摄时间间隔为6个月。椎体畸形的患病率和畸形的特异性随不同标准而显著不同。使用3个标准差的截止值，乳腺癌妇女椎体畸形的患病率为46%。使用其他方法，畸形的患病率从33%到74%不等。在6个月的时间间隔内，25%的乳腺癌患者使用我们的方法持续61个畸形，其中只有8%是由重复性错误引起的。通过其他方法评估时，出现新畸形的患者数量增加了两倍（45%-53%），但再现性误差可能占新畸形的21%。这些误差的大小和分布对骨质疏松症临床试验中药物的表观疗效具有重要意义。我们开发的用于评估脊柱侧位X线片上椎体畸形的快速半自动化技术具有很高的特异性，并减少了再现性误差对患病率和发病率估计的影响。在人群研究和前瞻性临床试验中，该方法应证明在评估椎体畸形方面的价值。
The absence of specific criteria for the definition of vertebral fracture has major implications for assessing the apparent prevalence and incidence of vertebral deformity. Also, little is known of the effect of using different criteria for new vertebral fractures in clinical studies. We therefore developed radiological criteria for vertebral fracture in women for assessing both the prevalence and the incidence of vertebral osteoporosis in population and in prospective studies and compared these with several other published methods. Normal ranges for vertebral shape were obtained from radiographs in 100 women aged 45-50 years. These included ranges for the ratios of anterior/posterior, central/posterior and posterior/predicted posterior vertebral heights from T4 to L5. The predicted posterior height was calculated from adjacent vertebrae. In contrast to other methods. our definition of fracture required the fulfilment of two criteria at each vertebral site, and was associated with a lower apparent prevalence of fracture in the control women due to a lower false positive rate. The prevalence and incidence of vertebral deformity using different criteria were then compared in a series of women with skeletal metastases from breast cancer in whom radiographs were obtained 6 months apart. The prevalence of vertebral deformity and the specificity for deformity varied markedly with differing criteria. Using a cut-off of 3 standard deviations the prevalence of vertebral deformity in the women with breast cancer was 46%. Using other methods, the prevalences of deformity ranged from 33% to 74%. Over a 6-month interval 25% of patients with breast cancer sustained 61 deformities using our method, of which only 8% resulted from errors in reproducibility. The number of patients sustaining new deformities was increased twofold when assessed by other methods (45%-53%), but errors of reproducibility may have accounted for 21% of the new deformities. The magnitude and distribution of these errors have important implications for the apparent therapeutic efficacy of agents in clinical trials of osteoporosis. The rapid semi-automated technique for assessing vertebral deformities on lateral spine radiographs that we have developed has a high specificity, and reduces the impact of errors of reproducibility on estimates of prevalence and incidence. The method should prove a value in assessing vertebral deformity both in population studies and in prospective clinical trials.